Thoracic endovascular grafts recalled over coating scrapings that may embolize
Cook Medical is recalling 695 Zenith Alpha 2 Thoracic Endovascular Grafts because affected devices may contain PTFE coating scrapings that could be released during deployment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The Zenith Alpha 2 Thoracic Endovascular Graft, catalog prefix ZTA2, is being recalled across a range of reference part numbers including ZTA2-P-40-117-W, ZTA2-P-40-167, ZTA2-P-42-121 and ZTA2-P-42-173.
Affected devices may contain PTFE coating scrapings. The scrapings could be released during device deployment, potentially causing intravascular embolization.
The recall covers 695 units, distributed domestically across states including Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia. The FDA has classified the recall as Class I.
Facilities should identify affected part and lot numbers, quarantine them and follow Cook Medical's instructions.
The recalled product
- Product
- Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125…
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Vascular graft
- Affected units
- 695
Distribution
Related recalls
Same manufacturer · Cook Medical Incorporated
See all →- HighCook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels
FDA (Devices) · 2024-05-22
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22
- ModerateVena Cava Filter Sets Recalled for Instruction for Use Documentation Updates
FDA (Devices) · 2022-04-13
- LowCook Celect Platinum Vena Cava Filter Set Instructions Recall
FDA (Devices) · 2022-04-13
- LowCook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
FDA (Devices) · 2019-03-27
Same hazard · particulate release
See all →- SevereCardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System
FDA (Devices) · 2014-08-20
Similar recalls
- CriticalCook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts
FDA (Devices) · 2017-08-16
- HighCook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing
FDA (Devices) · 2020-07-15
- HighCook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue
FDA (Devices) · 2020-09-23
- HighCook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Safety Lock Knob
FDA (Devices) · 2019-06-26
- HighCook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts
FDA (Devices) · 2020-03-04
- SevereMedtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects
FDA (Devices) · 2021-03-17